BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 4-LAYER TISSUE GRAFT

    MDR report key: 3800377 · Received April 3, 2014

    Report

    Report Number
    1835959-2014-00095
    Event Type
    Injury
    Date Received
    April 3, 2014
    Report Date
    April 2, 2014
    Manufacturer
    COOK BIOTECH INC
    Product Code
    PAG
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. IMPLANT DATE NOT UNK. PRODUCT MANUFACTURE DATE UNK AS LOT NUMBER UNK. ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. THIS MDR IS RELATED TO MDR #1835959-2014-00094. INVESTIGATION INTO THIS CLAIM HAS INCLUDED A REVIEW OF THE CLAIM ALLEGATIONS, A REVIEW OF THE CLAIM ALLEGATIONS, A REVIEW OF CLAIM ALLEGATIONS, AND ALL OTHER COMMUNICATION AND INVESTIGATION INTO THIS REPORT/CLAIM IS BEING HANDLED BY OUR ATTORNEY. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN 4-LAYER TISSUE GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNK. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTORNEY. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED, THAT ALTERS OUR CONCLUSION TO THIS COMPLAINT, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH 4 DEVICES BETWEEN (B)(6) 2011 AND (B)(6) 2013. THE PT USED A BIODESIGN 4-LAYER TISSUE GRAFT ON AN UNSPECIFIED DATE, AT THE SURGERY CENTER AT HEALTH CENTER, (B)(6) BY (B)(6) M.D. TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. THE PT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS PRODUCT BEING IMPLANTED IN THE PT, THE PT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT. RECORDS INDICATE THAT THE PT HAD 4 DEVICES IMPLANTED INCLUDING 2 COOK DEVICES AND PROLIFT DEVICES. THE PROLIFT DEVICES ARE LISTED AS GYNECARE PROLIFT + M LOT #3453327, AND A PROLIFT PERMANENT MESH LOT NUMBER UNK. THERE ARE 4 LISTED IMPLANTATION DATES BUT WE ARE UNABLE TO ASSOCIATE WHICH DATES CORRELATE TO WHICH PRODUCTS. IMPLANT DATES ARE LISTED AS (B)(6) 2011, (B)(6) 2011, (B)(6) 2012, AND (B)(6) 2013. THREE OF THESE SURGERIES OCCURRED AT THE SURGERY CENTER AT HEALTH CENTER, (B)(6) WITH DR. (B)(6). THE FINAL SURGERY OCCURRED AT COMMUNITY HOSPITAL, (B)(6) WITH DR (B)(6). THE FOLLOWING INFORMATION WAS NOT PROVIDED BY THE COMPLAINANT: SPECIFIC INFORMATION OF THE ALLEGED INJURY, SPECIFIC INFORMATION REGARDING WHETHER INTERVENTION WAS PERFORMED, SPECIFIC INFORMATION REGARDING WHY INTERVENTION WAS PERFORMED OR WHAT TYPE / TO WHAT EXTENT INTERVENTION WAS PERFORMED, SPECIFIC CORRELATION BETWEEN DEVICE PERFORMANCE AND ALLEGED INJURY, CURRENT PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200395 BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES PAG COOK BIOTECH INC NA LB544882

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability NOT PROVIDED BY COMPLAINANT